2022, Clinical Pharmacology and Drug Development

Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

Drug Development

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies

Antibody Drug Conjugates: windows of opportunity

Drug Target Review

JULY 4, 2023

However, a more detailed look into the clinical data suggests that there is room for further dose optimisation, and this is exemplified by the small molecule drug Sotorasib. Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering.

Small Molecule

Small Molecule Drugs Clinical Pharmacology Trials

In Silico Modeling Unveils a New Era in Rare Disease Drug Development

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

Drug Development

Drug Development Disease Clinical Trials Drugs

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Alta Sciences

SEPTEMBER 20, 2023

In development since 2022, the project has so far seen the completion of safety assessment utilizing intranasal administration at Altasciences’ nonclinical site in Columbia, MO. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.

Virus

Virus Clinical Pharmacology Drugs FDA Approval

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Clinical Trials

ATICAPRANT

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] Jump up to: a b Browne CA, Wulf H, Lucki I (2022).

Treatment

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science

Science FDA Trials Clinical Pharmacology

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

FDA

FDA Science Regulations Production

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

JULY 28, 2023

In a September 2022 blog post , Califf acknowledged the broad scope of the crisis, saying ,“The opioid crisis has evolved beyond prescription opioids into a broader drug overdose crisis, largely driven by illicit fentanyl and its analogs. FDA’s 2020 draft guidance discusses PBPK analyses for oral drug product development.

FDA

FDA Pharmacokinetics Clinical Pharmacology Government

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

While Project Beyond Breakthrough (anticipated to launch its pilot program at the end of 2022) and Project Site Selector (slated to host several meetings in 2023) never quite materialized, others like Project FrontRunner , Project Optimus , and Project Orbis saw frequent mentions throughout the year.

FDA

FDA Science Clinical Trials Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Clinical Trials Regulations

How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Image Thumbnail_diversity in clinical trials_VAbutton.jpg Synopsis Representation and inclusion of various minority groups is crucial for medical research.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics

Beyond ELISA: the future of biomarker validation

Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. 1 The journey to qualifying biomarkers for clinical and regulatory use is fraught with challenges, leading to a remarkably low success rate.

Drug Development

Drug Development Regulations Laboratories FDA

Drug Discovery Digest

Understanding the Regulatory Environment in Japan for Generic Drug Development

Antibody Drug Conjugates: windows of opportunity

Trending Sources

In Silico Modeling Unveils a New Era in Rare Disease Drug Development

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

ATICAPRANT

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

How Improving Diversity Can Benefit Clinical Trials

Beyond ELISA: the future of biomarker validation

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